The Effect of Instrumented and Non-Instrumental Perineal Massage on Birth Results in the Active Phase of Labor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Visual analog scale
研究概览
简要总结
Today, the increase in the costs of applications in the health care system makes it difficult for easy and inexpensive methods to be used based on evidence. In this study, the episiotomy rate, episiotomy length, perineal pain at birth and postpartum period, perineal trauma, newborn 1st min. and 5 min. It was planned as a Randomized Controlled Experimental study to examine the effect of APGAR score on birth outcomes such as the duration of the first and second stages of labor and birth satisfaction.
The universe of the research was carried out between December 2021-2022 in University Hospital and City Hospital Pregnant women at 38-42 weeks of gestation who are admitted to the maternity ward to give birth. Power analysis was performed using the GPower program in order to sample size. In determining the sample size, the article titled "The Effect of Perineal Massage During Labor in Nulliparous Women on Birth Comfort, Perineal Pain and Trauma" (Yaşar, 2019) was used. Considering the total mean scores of the GCS scale in intervention and control groups, Type 1 error amount was 0.01, test power was 0.99, and effect size was 1.1276841; The minimum required sample size was determined as 80 (40 interventions + 40 control groups) for the intervention and control groups. In line with these data, it was decided that the sample size would be 120 pregnant women who agreed to be in the study and met the inclusion criteria, 40 in the intervention-1 group to be given instrumental perineal massage, 40 in the intervention-2 group that would receive non-instrumental perineal massage, and 40 in the control group.
Frequency and mean values will be used in the evaluation of descriptive data, and independent sample t-test, chi-square test, fisher chi-square test and ANOVA will be used in the analysis of data showing normal distribution. The Mann Whitney U test is planned to be used in the analysis of data that do not show normal distribution. Normal distribution in the analysis of the relationship between prenatal instrument perineal massage and GCS scores, quality of pain, length of episiotomy, condition of the perineal region, duration of the first and second stages of labor, total delivery time, APGAR 1st and 5th minute scores, and parameters related to postpartum satisfaction Pearson correlation test will be used. All the results will be evaluated at the 95% confidence interval, at the 0.05 significance level.
详细描述
Randomization: In order to prevent the women in the intervention and control groups from being influenced by each other, a random selection was made between the two hospitals where the study would be conducted by drawing lots. According to this election, Tekirdag Dr. The women who will be included in the study from İsmail Fehmi Cumalıoğlu City Hospital will be included in the control group, and the women from the Tekirdağ Namık Kemal University Hospital will be included in the Intervention 1 and Interference 2 groups. Pregnant women to be sampled within intervention 1, intervention 2 and control groups will be determined by systematic random sampling method, one of the probabilistic sampling methods. The distribution within the group was made with a simple random selection method using the computer program module (https://www.calculatorsoup.com/calculators/statistics/random-number-generator.php). According to these results, the pregnant women to be included in the group are listed below in order of admission to the hospital.
Intervention Group 1 (Instrumental perineal massage group); Between October 2020 and March 2021, 86 women had normal vaginal deliveries in the obstetrics clinic of Tekirdağ Namık Kemal University Hospital. In this study, which was planned with reference to this number, the number of pregnant women to be included in the intervention1 group was made using a simple random selection method using the computer program module (https://www.calculatorsoup.com/calculators/statistics/random-number-generator.php). The order of application to the intervention 1 group 1. 4. 5. 8. 11. 14. 16. 20. 21. 23. 24. 25. 28. 29. 33. 34. 35. 39. 40. 43. 44. 46. 47 Pregnant women who are 52. 53. 56. 58. 59. 63. 64. 65. 70. 71. 72. 75. 76. 79. 82. 83. 86. will be taken.
Intervention Group 2 (The group that will receive manual perineal massage); Between October 2020 and March 2021, 86 women delivered vaginally to Tekirdağ Namık Kemal University Hospital's obstetrics clinic. In this study, which was planned with reference to this number, the number of pregnant women to be included in the intervention 2 group was made using a simple random selection method by using the computer program module (https://www.calculatorsoup.com/calculators/statistics/random-number-generator.php). The order of application to the initiative 2 group 2. 3. 6. 7. 9. 10. 12. 13. 15.17. 18. 19. 22. 27. 30. 31. 32. 36. 38. 41. 42. 45. 48. 49. 51. 54. 55. 60. 61. 66. 67. 68. 69. 73. 74. Pregnant women who are 77. 78. 80. 81. 85. will be accepted. The pregnant woman who was excluded from the study due to any of the reasons stated in the randomization will be replaced by the pregnant who was admitted for the next delivery and her sequence number will be given to the next pregnant woman.
Control Group; Tekirdag Dr. Between October 2020 and March 2021, 252 women delivered vaginally to İsmail Fehmi Cumalıoğlu City Hospital's maternity clinic. In this study, which was planned with reference to this number, the number of pregnant women to be included in the control group was made using a simple random selection method using the computer program module (https://www.calculatorsoup.com/calculators/statistics/random-number-generator.php). Tekirdag Dr. to the control group. The order of application to İsmail Fehmi Cumalıoğlu City Hospital as of October 2021 is 9 15 18 20 34 43 44 46 49 53 60 64 65 67 77 78 81 84 102 103 108 118 120 128 131 136 152 158 163 171 178 179 184 186 187 198 205 206 228 230 pregnant women will be taken.
If the hospital in the intervention and control groups receives the news that there is a pregnant hospitalization meeting the inclusion criteria at the same time, the pregnant women in this center will be given priority, since the number of births in the hospital planned to be included in the intervention group is lower.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the design of the study, single or double masking cannot be done.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Volunteer to participate in the study
- •No vision and hearing problems
- •At least primary school graduate and no language problems
- •Those between the ages of 18-35
- •38th-42nd of pregnancy. in the week
- •Does not feel uncomfortable being touched by the genital area
- •Those who are willing to have a normal delivery and have a vaginal delivery indication
- •During the first stage of labor, analgesia and anesthesia are not used.
- •Head presenter
- •Single pregnancy
- •Those who do not have a risky pregnancy (Dystosiler, Presanta previa, threat of premature birth, premature rupture of membranes, preeclampsia, eclampsia, hyperemesis gravidarum, ablatio placenta, placenta accreta, intrauterine growth retardation, cord anomaly, vaginal bleeding, etc.)
排除标准
- •Non-Turkish citizens
- •Planned cesarean section
- •Having genital infection
- •A different perineal massager
- •Pregnant women with narcotic and analgesic addiction and who were administered narcotic analgesics during the data collection process.
- •Known chronic disease (heart disease, hypertension, diabetes, kidney disease, etc.) systemic disease
- •Having a neurological disease
- •Non-pharmacological pain control methods at birth (respiratory exercise techniques, massage, intradermal water injection, relaxation and relaxation methods, mental/mental stimulation, Transcutaneous electrical nerve stimulation, etc.). using.
结局指标
主要结局
Visual analog scale
时间窗: The VAS is evaluated postpartum10th day.
It is a scale used to evaluate the severity of pain. participants are asked to mark or say the point on the line numbered from zero to 10 that corresponds to the pain.Zero points; While expressing no pain, 10 points indicates the most severe pain experienced.
Labor Evaluation Form Part I
时间窗: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, the questionnaire will be applied at the beginning of the birth process, before the vaginal dilatation is 4 cm.
I. It will be applied in the latent phase of labor (cervical dilatation: 0-4 cm). II.It will be applied in the active phase of labor (cervical dilatation: 4-8 cm). III.Until two days after birth
Labor Evaluation Form Part II
时间窗: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, the questionnaire will be applied at the beginning of the birth process, before the vaginal dilatation is 8 cm.
It will be applied during the active period of labor (cervical dilatation: 5-8 cm). II.It will be applied in the active phase of labor (cervical dilatation: 4-8 cm). III.Until two days after birth
Labor Evaluation Form Part III
时间窗: This form is evaluated within 48 hours of postpartum
It will be applied within the first 48 hours after the birth is completed.
REEDA Scale
时间窗: The REEDA score is evaluated in the 48th hour after delivery.
This scale includes five factors that indicate perineal wound healing. These; These are redness (redness), edema (edema), ecchymosis (ecchymosis), discharge (discharge), approximation (approaching wound ends). Each factor takes values between 0-3. A total REEDA score (0-15) is obtained by evaluating these five improvement factors. The lowest score is 0 points, the highest score is 15 points. Higher scores indicate more tissue trauma.
Birth satisfaction scale
时间窗: This form is evaluated postpartum 10th day.
The original of the scale used to evaluate women's perceptions of birth satisfaction is 30 items and is a five-point Likert type. It consists of 3 main themes: quality of care, personal characteristics of women and stress experienced during childbirth. A minimum of 30 and a maximum of 150 points can be obtained from the scale. The higher the score, the higher the level of satisfaction.
次要结局
- Visual analog scale(The VAS is evaluated within 48 hours of postpartum after delivery)
- REEDA Scale(The REEDA score is evaluated in the postpartum 10th day after delivery.)
研究者
Meryem Metinoglu
Lecturer
Namik Kemal University